Proton Pump Inhibitors (PPIs) and Fracture Risk

The Australian Self-Medication Industry (ASMI) is aware of a
newly published observational cohort study conducted in Denmarki
which identifies a potential association between the long-term use
of high-dose PPIs and reduced efficacy of alendronate (oral
bisphosphonate) in preventing hip fractures amongst elderly
patients.

This was an observational cohort study and therefore had some
limitations as well as a number of strengths. One of the important
limitations was that it could not determine whether the change in
hip fracture risk was causally related to PPI use or whether it was
due to other factors such as comorbidities or medication
compliance. In assessing their findings, the authors stated
that:

"In our study, PPI users benefited less from alendronate in
terms of hip fracture risk than did nonusers. We included both
comorbidity and comedication terms in the base models, but because
the 2 groups may differ in other, unmeasured confounders it remains
possible that the difference in alendronate response is driven not
by PPIs themselves but by differences in nonskeletal risk factors
for osteoporosis that would not respond to bisphosphonates."

ASMI Regulatory and Scientific Affairs Director, Steven Scarff
noted the following important findings from the study:

For Defined Daily Doses of PPI below 360 there was no impact on
fracture risk. For persons younger than 70 years of age there was
no impact on fracture risk.

This study reveals a loss of protection against hip fracture
with alendronate in elderly patients taking high doses of PPIs for
long periods of time. Of relevance to over-the-counter (OTC) users
of PPIs, this study also shows that:

Short term PPI use was not associated with a higher fracture
risk compared to no PPI use. The fracture risk for persons under 70
years of age is unchanged whether the person uses a PPI or
not.

PPIs that are available OTC in Australia are for short-term use (a
maximum of 14 days) at half the Defined Daily Doses used in the
Abrahamsen study and are Pharmacist Only Medicines. No medicine is
without risk and this study will assist pharmacists in determining
the suitability of PPIs for each individual.
__________________________________________________________________About ASMI: The Australian Self-Medication
Industry (ASMI) is the peak industry body for the Australian self
care industry representing consumer healthcare products including
over-the-counter medicines and complementary medicines. ASMI's
mission is to promote better health through responsible self-care.
This means ensuring that safe and effective self-care products are
readily available to all Australians at a reasonable cost. ASMI
works to encourage responsible use by consumers and an increasing
role for cost-effective self-medication products as part of the
broad national health strategy. www.asmi.com.au